FDA Browser

Last synced on 20 December 2024 at 11:05 pm

VITROS HBeAg

Page Type: PMA Approval
PDF: FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant: Ortho-Clinical Diagnostics, Inc.
Trade Name: VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 5/11/2011
Days to Decision: 511 days
Decision Code: APPR
FDA Decision: Approval

FDA Browser

VITROS HBeAg

Page Type: PMA Approval
PDF: FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant: Ortho-Clinical Diagnostics, Inc.
Trade Name: VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 5/11/2011
Days to Decision: 511 days
Decision Code: APPR
FDA Decision: Approval